Manufacturing Separable Pouches With A Center Cut Blade

ABSTRACT

A system for manufacturing a plurality of separable pouches comprising a means for forming sealed pouches, a center cut blade and a means for segregating each sealed pouch with the center cut blade is described. The means for forming the sealed pouches includes placing a plurality of different tablets corresponding to different medications into each sealed pouch. The center cut blade includes a side cut on each end of the blade, a center cut in the middle of the blade, and at least one perforation cut between each side cut and the center cut. The means for separating each sealed pouch with the center cut blade provides each sealed pouch with a sealed top end, a sealed bottom end, and two sides, in which at least one side is also sealed.

CROSS REFERENCING

The present patent application claims priority from provisional patentapplications 61/045,160, 61/045,166, and 61/045,171, all filed Apr. 15,2008. The present application is a continuation-in-part ofnonprovisional application Ser. No. 11/923,321, filed Oct. 24, 2007,which is a continuation-in-part of nonprovisional patent applicationSer. Nos. 11/796,123, 11/796,124, and 11/796,125 filed Apr. 25, 2007,which all claim benefit of provisional applications 60/795,370,60/795,446, and 60/795,413, filed Apr. 26, 2006, and provisionalapplication 60/854,341, filed Oct. 24, 2006. This application is acontinuation-in-part of nonprovisional application Ser. No. 11/241,783,filed Sep. 30, 2005, which is related to provisional application60/615,267, filed Oct. 1, 2004. All applications listed in thisparagraph are hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention relates to a system for manufacturing a pluralityof separable pouches with a center cut blade. More particularly, theinvention relates to forming sealed pouches and separating each sealedpouch using the center cut blade.

BACKGROUND

Approximately fifty to seventy percent of all prescription medicationsin the U.S. are taken incorrectly. The effects of this prescriptionmisuse account for 3.1 million nursing home admissions each year. Morepatients in the U.S. die each year from medication mismanagement thanfrom AIDS and automobile accidents combined, and it is estimated that125,000 deaths per year are caused by improper use of prescriptiondrugs.

One of the major problems in taking prescribed daily medicationsemanates from patients having to take more than one medication in theform of pills or tablets. A principal concern is determining whether allmedications are in compliance with the prescribed daily regimen. Manytimes this concern is compounded by the requirement that portions of thedifferent medications must be taken at different times during the day.

The fear of taking improper dosages of prescribed medication can beparticularly acute in the elderly, many of whom have some degree ofmental dementia and can easily be confused as to whether they have takenall of their medications at the correct time. Some patients havedifficulty sorting out the medications prior to taking them and takingthe medication in a timely manner. Providing medications to disabled orincapacitated individuals can also be complicated because one caregivermay oversee the medication of many patients.

One solution to the problem of taking multiple medications is topre-package the multiple medications so that users can take thepre-packaged medications at a predetermined time. Generally, thesemethods of pre-packaging medications are targeted to patients that maylack maturity or mental capacity to take the correct medications at thecorrect time. For example, young children in a school or campground, andelderly individuals in elder care centers, or nursing homes are targetgroups for the pre-packaging of medications. Some of the pre-packagedmedications are placed in a small plastic bag, which may be easilymisplaced. Other pre-packaged medications are placed in sealed cups thatare difficult to open.

Although multiple prescription filling systems are available, e.g. theMcKesson PACMED system, these systems have limited capabilities. Forexample, these filling systems fail to assemble a multiple prescriptionorder that can be easily transported and administered. Additionally,these filling systems fail to effectively organize the multipleprescription medications. Furthermore, the filling systems fail toorganize the multiple prescription containers. Further still, thefilling systems fail to provide a compliance packaging solution.

SUMMARY

A system for manufacturing a plurality of separable pouches comprising ameans for forming sealed pouches, a center cut blade and a means forsegregating each sealed pouch with the center cut blade is described.The means for forming the sealed pouches includes placing a plurality ofdifferent tablets corresponding to different medications into eachsealed pouch. The center cut blade includes a side cut on each end ofthe blade, a center cut in the middle of the blade, and at least oneperforation cut between each side cut and the center cut. The means forseparating each sealed pouch with the center cut blade provides eachsealed pouch with a sealed top end, a sealed bottom end, and two sides,in which at least one side is also sealed. Each sealed pouch is joinedto an adjacent pouch by a plurality of tearable ribbons. Additionally,each sealed pouch includes a side cut on each side of the top end andbottom end of the sealed pouch, a center cut on the top end and bottomend of the sealed pouch, and at least one perforation between each sidecut and the center cut.

Additionally, a system for manufacturing a plurality of separablepouches comprising a heated roller and a center cut blade is alsodescribed. The heated roller is configured to seal each pouch. Eachpouch includes the plurality of different tablets corresponding todifferent medications and each sealed pouch includes a sealed top end, asealed bottom end, and two sides, in which at least one side is alsosealed. The center cut blade is configured to be affixed to the heatedroller that segregates each sealed pouch. The center cut blade comprisesa side cut on each end of the blade, a center cut in the middle of theblade, and a plurality of perforation cuts between each side cut and thecenter cut.

Furthermore, a system for manufacturing a plurality of separable pouchescomprising a heated roller, a center cut blade with a center cut that islonger than each of the side cuts, and at least one perforation with atleast two tearable ribbons between each side cut and the center cut isdescribed.

DRAWINGS

The present invention will be more fully understood by reference to thefollowing drawings which are for illustrative, not limiting, purposes.

FIG. 1A shows a pair of prior art heated rollers that cut and seal theillustrative pouches.

FIG. 1B shows a side view of a prior art cutting block and a prior artcutting blade shown in FIG. 1A.

FIG. 1C shows a side view of the prior art cutting block and the priorart cutting blade that are both fixedly coupled to the heated rollers ofFIG. 1A.

FIG. 1D shows a sealed prior art pouch with a single side cut adjacentto the prior art cutting blade.

FIG. 2A shows an isometric view of a center cut cutting blade that isused to generate a separable pouch with a center cut.

FIG. 2B shows an inverted side view of the center cut blade shown inFIG. 2A.

FIG. 2C shows an illustrative elevational side view of a cutting blockand the center cut cutting blade.

FIG. 2D shows an exploded view of the cutting block and the center cutcutting blade.

FIG. 2E shows an illustrative strip that includes a sealed center cutpouch.

FIG. 3A shows an illustrative sealed center cut pouch with threeperforations and four tearable ribbons on each side of the center cut.

FIG. 3B shows an illustrative sealed center cut pouch with fourperforations on each side of the center cut.

FIG. 3C shows an illustrative sealed center cut pouch with fiveperforations on each side of the center cut.

FIG. 4A shows a group of seven separable pouches, wherein each pouchcomprises a plurality of different tablets.

FIG. 4B shows an exploded view of the illustrative front side of one ofthe sealed center cut pouches that is included in the strip of pouches.

FIG. 4C shows an exploded view of the illustrative back side of thepouch in FIG. 4B.

FIG. 5A shows a plan view of blank used to form a foldable boxconfigured to receive a plurality of center cut pouches.

FIG. 5B shows an isometric view of an assembled box without any printplaced on the blank.

FIG. 6A shows a space for a label on a pre-assembled blank that issimilar to the blank described in FIG. 5A.

FIG. 6B shows a variety of printable areas on the back face of theassembled box.

FIG. 7A shows an illustrative method for opening the assembled box withone hand.

FIG. 7B shows a folded box with an exposed label area or print areadefined by the top wall and top side flaps.

FIG. 8A shows a strip of seven separable pouches.

FIG. 8B shows a folded strip of seven separable pouches.

FIG. 9A shows another illustrative folded box with a label area definedby the top wall.

FIG. 9B shows the illustrative folded box of FIG. 9A in a closedposition.

FIGS. 10A-10G show an illustrative label on the folded box.

FIG. 11 shows another illustrative exterior label that is applied to theexterior of the assembled box and is visible when the assembled box isin a closed position.

FIG. 12 shows an illustrative grouping for a 30-day tablet regimen forthe patient management system.

FIG. 13 shows a secondary container that receives four primarycontainers or assembled boxes.

FIG. 14 shows a plurality of different secondary containerscorresponding to four different dosage periods.

FIG. 15 shows an illustrative flowchart of a method for compliancepackaging for the patient medication management system.

FIGS. 16A-16C show an isometric view of the 30-day tablet dispensingcontainer.

FIGS. 17A-17E show a flat plan view of an illustrative label.

FIG. 18 shows a first side view of the front side wall for the unopened30-day tablet dispensing container.

FIG. 19 shows a second side view of the back side wall of the 30-daytablet dispensing container.

FIGS. 20A-20B show a third side view of the illustrative right-side wallof the 30-day tablet dispensing container.

FIG. 21 shows a fourth side view of the illustrative left-side wall ofthe 30-day tablet dispensing container.

FIG. 22 shows a top view of the top wall of the unopened 30-day tabletdispensing container.

FIG. 23 shows a bottom view of the 30-day tablet dispensing container.

FIG. 24 shows an illustrative front view of the opened 30-day tabletdispensing container that reveals illustrative pouches.

DESCRIPTION

Persons of ordinary skill in the art will realize that the followingdescription is illustrative and not in any way limiting. Otherembodiments of the claimed subject matter will readily suggestthemselves to such skilled persons having the benefit of thisdisclosure. It shall be appreciated by those of ordinary skill in theart that the apparatus and systems described herein may vary as toconfiguration and as to details. Additionally, the methods may vary asto details, order of the actions, or other variations without departingfrom the illustrative method disclosed herein.

The systems, apparatus and methods described herein provide the correctmedications and dosages at the right time. The packaging is designedwith clear images and names to simplify the process of determining theappropriate medications to take at the appropriate time. Additionally,the patient medication management system and method described hereineliminates that worry of taking the wrong medication at the wrong time,and eliminates the need to the manually open and organize prescriptionseach week. Furthermore, the system and method described herein gathersall the patient's medicines together in one package, and clearly showsthe proper dosage time.

The terms “tablets”, “medications” and “medicaments” as used hereinrefer to medications, pharmaceuticals, nutriceuticals, vitamins,capsules, gel caps, pills and other such medicinal or nutritionalpreparations for oral use as would be appreciated by those of ordinaryskill in the art of pharmacy.

The systems, apparatus and methods described herein provide assurancesof the proper dosages at the proper period. Additionally, caregivers andpatients get the assurance that the patient is getting the rightmedications and staying compliant with those medications. Furthermore, atime saving solution for dispensing tablets, medications and vitamins isdescribed.

One of the patient medication management systems provides a compliantpackaging solution. For purposes of this patent, the term “compliantpackaging” refers to packaging tablets so that they are administered ina manner that complies with one or more prescriptions. Additionally,compliant packaging may also refer to providing reminders for takingmedications and/or recording that the medications have been consumed.

By way of example and not of limitation, compliance packaging mayinclude three elements: firstly, an action is initiated by a patientand/or caregiver with the compliance package; secondly, the compliancepackage dispenses at least one tablet as a result of the action taken bythe patient and/or caregiver; and thirdly, the compliance packagerecords the dispensing of the tablet. An illustrative example of a“compliance package” is the well-known birth control “dial pack”package, in which there are twenty-eight tablets in a blister packagethat are in a circular configuration (not shown). To consume the tablet,the patient pushes on the transparent plastic material and the tabletpierces a foil backing. After the tablet is dispensed from the dialpackage, a record is left on the dial pack package, i.e. a pressedplastic housing and pierced foil backing.

Compliant packaging may also include a compliant package having aplurality of different tablets corresponding to one or moreprescriptions from one or more medical doctors. The compliant package isconsumed at a predetermined interval consistent with the prescription.Some compliant packaging solutions may not record that each of thetablets is consumed.

One of the illustrative patient medication systems described hereinsatisfies the requirements for a compliance package because an action isrequired by the patient or caregiver that requires identifying theappropriate dosage period, e.g. morning, and selecting the appropriatepouch. The patient or caregiver records the consumption of themedication by removing the packet containing the appropriate medicationfrom the container and consuming the medication. Since the packet isimprinted with a dosage time period and date for consumption, a patientor caregiver can tell at a glance whether the medication for the currentdate and dosage period has already been consumed or whether it remainsto be taken.

Referring to FIG. 1A there is shown a pair of prior art heated rollersthat cut and seal the illustrative pouches that hold the tablets. Theillustrative pouch 12 is cut and perforated by a cutting blade 14 andcutting block 16 that is fixedly coupled to heated roller 18 and heatedroller 20, respectively. The heated rollers also seal the end 19 of thepouch 12. The heated roller 18 includes a second cutting blade 22 thatcuts, perforates and seals the opposite end of the pouch 12 (not shown).The second heated roller 20 includes a second cutting block 24 that islocated at an equidistant point from the cutting block 16. Theillustrative rollers 18 and 20 also seal the edges of the pouch. Theillustrative combination of the heated rollers 18 and 20 and cuttingblade 14 and cutting block 16 may be found in a PACMED™ system sold bythe McKesson Corporation from Pennsylvania.

Referring now to FIG. 1B there is shown a side view of the cutting block16 and cutting blade 14 that are both fixedly coupled to the heatedrollers of FIG. 1A. The cutting blade 14 has a flat face 26 and apointed edge 28.

In FIG. 1C there is shown a side view of the cutting block 16 andcutting blade 14 that are both fixedly coupled to the heated rollers ofFIG. 1A. Generally, block 16 is a rectangular block shaped metal alloy.The cutting blade 14 may be composed of the same or similar metal alloyand includes a single side cut 30 of a predetermined length and aplurality of smaller cuts such as 32 a that score or cut the pouch 12and provide perforations between the heat-sealed edges of each pouch.

In FIG. 1D there is shown an illustrative sealed prior art pouch with asingle side cut adjacent to the prior art cutting blade 14. Theillustrative pouch 34 includes a single cut 36, a plurality ofperforations such as perforation 38 a, a sealed top edge 40, a sealedbottom edge 42, and a sealed side edge 44. In the illustrativeembodiment, the pouch 34 is formed by taking a plastic sheet composed ofa polymeric compound and folding the plastic sheet over and sealing theside edge 44 and the sealed bottom edge 42 and sealed top edge 40. Thelength of the single cut 36 is determined by the single side cut 30.

The plastic pouch materials may be obtained with the PACMED™ system andthe consumables are sold by the McKesson Corporation; however, thechemical and material properties of the plastic materials have not beenpublicly disclosed. Regardless, the inventors have discovered that thereare various limitations corresponding to the plastic pouch materials. Inthe embodiments disclosed herein, the plastic “pouch” material is soldas a consumable for the PACMED system. Alternatively, an AUTOMEDpackaging system may also be used.

In general, the plastic pouches generated by the PACMED machines do nottear easily. The single cut 36 and multiple perforations 38 a result inthe tearing of the existing pouch and adjacent pouches. Although, eachthe perforations 38 a are intended to facilitate horizontal tearing, theperforations 38 a regularly result in a tear taking a circuitous routethat tears the existing pouch or adjacent pouch. Thus, when a user tearsthe prior art pouches, there is a likelihood that the resulting tear isnot horizontal and tears the sealed pouch holding the tablets or theadjacent sealed pouch.

Additionally, it appears that there is a film grain 46 corresponding tothe plastic materials that result in vertical tearing of the pouches, sothat upon attempting to separate a first pouch from a second pouch, atear occurs with significant frequency on either pouch itself or theadjacent pouch that would result in tablets being spilt on a table orfloor. The complexity of this problem is magnified by the plastic pouchmaterials being sold exclusively by McKesson Corporation and there beingno alternative pouch materials that operate with the PACMED system.

Referring to FIG. 2A there is shown an isometric view of a center cutblade that is used to generate a separable pouch with a center cut. Thecenter cut blade 50 generates separable pouches that enable a patient orcaregiver to access the medications in the pouches without tearingadjacent pouches. The center cut blade 50 is fixedly coupled to heatedrollers 18 shown in FIG. 1A. The heated rollers 18 and 20 are configuredto seal each pouch and to also cut the plastic pouch material. Theillustrative cutting blade 50 has a top edge 52 and a bottom face 54.

Referring to FIG. 2B there is shown an inverted side view of the centercut blade shown in FIG. 2A. The top edge 52 of the center cut blade 50comprises a first side cut 56 having a c₁ length, a center cut 58 havinga c₂ length, and a second side cut 60 having a c₃ length. The first sidecut 56 and second side cut 60 are on each end of the blade 50. Thecenter cut 58 is in the middle of the blade 50 and is separated from thefirst side cut 56 by perforation cuts 62 a, 62 b and 62 c. On theopposite end, the second side cut 60 is separated from the center cut 58by the perforation cuts 64 a, 64 b, and 64 c. Each perforation is arelatively small cut compared to either the side cuts or the center cut.The center cut length is greater than the length of each side cut.

For example, in a broad illustrative embodiment the dimensions of thefirst side cut 56 c₁ length can range from 1.0 mm to 20.0 mm. Thedimensions of the second side cut 60 c₃ length can range from 1.0 mm to20.0 mm. The center cut 58 c₂ length can range from 1.0 mm to 50.0 mm.The number and size of perforation cuts can also vary. For example,there may 1 to 10 perforation cuts in the broad illustrative embodiment,and the width of the perforation cuts can vary from 0.1 mm to 2.0 mm.

In a more limiting embodiment, the dimensions of the first side cut 56c₁ length can range from 5.0 mm to 15.0 mm. The dimensions of the secondside cut 60 c₃ length can range from 5.0 mm to 15.0 mm. The center cut58 c₂ length can range from 20.0 mm to 40.0 mm. The number and size ofperforation cuts can also vary. For example, there may 2 to 5perforation cuts in the less broad illustrative embodiment, and thewidth of the perforation cuts can vary from 0.5 mm to 1.5 mm.

In the preferred embodiment shown in FIG. 2B, the length of first sidecut 56 is approximately 10 mm and for second side cut 60 isapproximately 10 mm. The center cut 58 is approximately 35, mm. In thepreferred embodiment, there are three perforation cuts resulting in fourtearable ribbons on each side of the center cut 58. The width of theperforation cuts is approximately 1.0 mm, and each of the tearableribbons is approximately 1.0 mm.

Referring to FIG. 2C, there is shown an illustrative elevational sideview of a cutting block 66 and the center cut blade 50. This profile ofthe center cut blade 50 and the cutting block 66 shows that the centercut blade 50 has the same profile as the prior art cutting blade 14shown in FIG. 1B. In operation, the center cut blade 50 and cuttingblock 66 are fixedly coupled to rotating heated rollers that effectivelycut and seal the pouch. The illustrative heated roller described hereinprovides a dual role, namely, the heated roller provides a means forforming sealed pouches because the heated roller is used to seal theplastic pouch material. Additionally, once the center cut blade isplaced in the heated roller, the combination provides a means forseparating each sealed pouch without tearing the existing sealed pouchor tearing the adjacent sealed pouch.

Referring to FIG. 2D, there is shown an exploded view of the cuttingblock and the center cut cutting blade. A more detailed view of thecenter cut blade 50 depicts the first side cut 56 adjacent to a firstu-shaped well 68 a that is adjacent the perforation cut 62 a. Note, theterms “u-shaped well” and “well” are used interchangeably. A secondu-shaped well 68 b follows and is adjacent to another perforation cut 62b that is also adjacent well 68 c. Well 68 c is also adjacent toperforation cut 62 c which is, in turn, adjacent to well 68 d. Adjacentto well 68 d is the center cut 58. The center cut 58 is separated fromthe second side cut 60 by the alternating combinations of theperforation cuts 64 a-64 c and wells 70 a-70 d. The first side cut 56and second side cut 60 are on each end of the blade 50. The illustrativefour wells 68 a-68 d and 70 a-70 d generate four ribbons on the plasticpouches that are between each side cut and the center cut that aredescribed in further detail below.

Referring back to FIG. 2A the u-shaped wells 68 a-68 d and 70 a-70 d arenot sharpened and do not cut the plastic pouch materials. As a result,“ribbons” are produced that connect or couple the pouches to oneanother.

The separable sealed pouches may then be grouped into of collections ofseven pouches (for the seven-day box), twenty-eight pouches, thirtypouches, or any other such combination. A plurality of sealed pouchesthat is grouped is also referred to as a “strip,” and the terms “strip”and “group of pouches” is used interchangeably in this patent. A typicalstrip includes seven pouches, twenty-eight pouches, or thirty pouches.In one embodiment described in further detail below, a reminder stripconsists of seven pouches, followed by an empty pouch with printing onthe pouch to remind the patient and/or caregiver to re-order, and tworemaining pouches. In another embodiment, there are twenty-eight pouchesfollowed by an empty pouch with printing on the pouch to remind thepatient and/or caregiver to re-order, and two remaining pouches

Referring now to FIG. 2E there is shown an illustrative strip 71 thatincludes a sealed center cut pouch 72. The illustrative pouch 72 isadjacent to pouch 74 and pouch 76. By way of example and not oflimitation, the illustrative pouch 72 comprises a sealed top end 78, asealed bottom end 80, and two sides, in which at least one side is alsosealed, e.g. side seal 82, and the other side is folded over. Eachillustrative pouch includes different tablets corresponding to differentmedications, vitamins, or other such medicinal or nutritionalpreparation for oral use.

Additionally, the illustrative pouch is joined to an adjacent pouch by aplurality of tearable ribbons 84 a-84 d adjacent to the first side cut85 a adjacent the top end 78. A similar grouping of tearable ribbons isalso adjacent the second side cut 85 b adjacent to the top end. Eachsealed pouch comprises side cuts 85 a and 85 b on each side of the topend 78 and side cuts 85 c and 85 d on each side of bottom end 80.

The illustrative embodiment shows a pouch with at least threeperforations between each side cut and the center cut. The first ribbon84 a is disposed between the first side cut 85 and the first perforation86 a. The second ribbon 84 b and third ribbon 84 c are each disposedbetween perforations 86 a, 86 b and perforations 86 b, 86 c,respectively. The fourth ribbon 84 d is disposed between the thirdperforation 86 c and the center cut 87 a. A similar configuration ofperforations and ribbons surround the center cut 87 b that is adjacentthe bottom end 80. In the illustrative example, the ribbons have a widthcorresponding to the width of the u-shaped well.

The resulting pouch can be opened on either side and the center cutprevents tearing the existing pouch or the adjacent pouch. In general,the pouch described minimizes the number of tearable ribbons therebyminimizing the likelihood of tearing the existing pouch or the adjacentpouch. Additionally, having the tearable ribbons at the edges of thepouch also minimizes the likelihood of tearing into the existing oradjacent pouches.

It shall be appreciated by those of ordinary skill in the art having thebenefit of this disclosure that the resulting pouch will vary dependingon the type of pouch material being used, the thickness or weight of thepouch material, the seal, the length of the cuts, the number of cuts,the length of the perforations, number of perforations, the width of thetearable ribbons, and the frequency of tearable ribbons. For example, inFIG. 3A there is shows the illustrative sealed center cut pouch 72described above with three perforations and four tearable ribbons oneach side of the center cut. In FIG. 3B there is shown an illustrativesealed center cut pouch 88 with four perforations on each side of thecenter cut. FIG. 3C depicts another illustrative sealed center cut pouch89 with five perforations on each side of the center cut.

Referring to FIG. 4A there is shown a group of seven separable pouches,wherein each pouch comprises a plurality of different tablets. Theseparable sealed pouches have been grouped into a collection of sevenpouches 90 that correspond to a seven day supply of medications. Aplurality of sealed pouches that is grouped is also referred to as a“strip,” and the terms “strip,” “group of pouches,” and “strip ofpouches” is used herein interchangeably.

Referring to FIG. 4B there is shown an exploded view of the illustrativefront side of one of the sealed center cut pouches 92 that is includedin the strip of pouches 90. The exploded view shows that a variety ofdata fields that are printed on the front of each pouch. In general, thedata fields provide information corresponding to each tablet within thepouch. The data fields includes: the name of the patient 94 a; the datethe tablets should be consumed 94 b; the time of day the tablets shouldbe taken 94 c; the name of the prescribed medication 94 d; the name ofthe corresponding generic 94 e; the dosage 94 f; and the prescriptionnumber 94 g. Additionally, an expiration date 94 h is included thatidentifies the medications should not be taken after the expirationdate.

Referring to FIG. 4C there is shown an exploded view of the illustrativeback side of the pouch 92 in FIG. 4B. The data fields include: the nameof patient 96 a; a bar code 96 b; the address of the facility thatfilled the pouches with tablets 96 c; and the telephone number 96 d foradditional information. The illustrative bar code associates the tabletsin the foldable box with a particular patient.

The illustrative seven-day strip 90 is then placed in an illustrativeseven-day container. An illustrative seven-day container is presented inFIG. 5A through FIG. 12. These illustrative containers are then placedin a secondary container such as described in FIG. 13 and FIG. 14.

Referring to FIG. 5A there is shown a plan view of a blank 110 used toform an assembled box 180 (shown in FIG. 5B) that holds a plurality ofpouches, wherein each pouch includes a plurality of different tablets.The foldable box is formed from a single piece of cardboard configuredto receive a plurality of pouches as described herein. The blank 110 isformed from a corresponding stamping die that presses against a largepiece of cardboard and cuts out the perimeter of the blank and forms thescores, holes and other cuts on the blank, in a manner well known in theart of box making. The scores are depressions in the blank 110 and areformed by projections on the dies that press into the corrugatedcardboard blank 110 sufficiently to form a score or fold line, but notcut all the way through the blank 110. The cuts or perforations in blank110 are formed by sharpened depressions on the die that cut all the waythrough the blank.

By way of example and not of limitation, the illustrative cardboard orblank 110 includes an outer smooth layer of paper and a thick interiorlayer. The outer smooth layer may receive printed text or images usingan illustrative laser printer, ink jet printer, or other such printingmeans.

The blank 110 comprises a top wall 112 that provides a closure for theassembled box 180 that is shown in FIG. 5B. Adjacent to the top wall 112are two top wall side flaps 116 a and 116 b that are separated by foldlines 114 a and 114 b, respectively. The combination of the top wall 112and the top wall side flaps 116 a and 116 b provides a printable areathat may be configured to receive toner or ink or even a labelcorresponding to a particular patient. Additional details about anillustrative label defined by the top wall 112 and top wall side flaps116 a and 116 b is described below.

A back wall 118 is adjacent to the top wall 112. The back wall 118 isbounded by back wall fold lines 120 a and 120 b that are adjacent backwall tabs 122 a and 122 b, respectively. The back wall 118 is separatedfrom the top wall 112 by a top wall/back wall fold line 124.

A bottom wall 126 is adjacent the back wall 118. The bottom wall 126 isbounded by bottom wall fold lines 128 a and 128 b. The illustrativebottom fold line 128 a includes two cuts, namely, cuts 130 a and 130 a′.Additionally, the bottom fold line 128 b also includes two cuts, namelycut 130 b and 130 b′. The bottom wall 126 is separated from the backwall 118 by a back wall/bottom wall fold line 132.

A first side wall 134 a and second side wall 134 b are both adjacent tothe bottom wall 126. The side walls 134 a and 134 b are adjacent to sidewall fold lines 136 a and 136 b, respectively.

A first side wall flap 140 a is adjacent the first side wall 134 a. Asecond side wall flap 140 b is adjacent the second side wall 134 b. Theside walls 134 a and 134 b are configured to receive text. Additionally,each side wall flap 140 a and 140 b comprises a pair of locking tabsincluding locking tabs 144 a and 144 a′ that are at the outer edge ofside wall flap 140 a and interface or are “locked” into cuts 130 a and130 a′. On the opposite end of the blank 110, locking tabs 144 b and 144b′ interface with cuts 130 b and 130 b′, respectively.

A front wall 146 is adjacent the bottom wall 126. The front wall 146 isbordered by front wall fold lines 148 a and 148 b. Front wall tabs 150 aand 150 b are adjacent the front wall fold lines 148 a and 148 b,respectively. Additionally, the front wall 146 is separated from thebottom wall 126 by a front wall/bottom wall fold line 152 and an edgeslot 154. The front wall 146 also includes a closing slot 156 and aplurality of circular cuts 158 where each cut has a corresponding foldline 160.

A front flap 162 is configured to interface with the closing slot 156.The front flap 162 is adjacent the top wall 112 and both elements areseparate by a front flap/top wall fold line 164. The front flap 162 alsoincludes a lip 166 that is bounded by arcuate edge 168 a and 168 b. Thelip 166 is received by the closing slot 156 of the front wall 146. Thefront flap 162 also comprises an opening 170 that is trapezoidal inshape, has rounded edges, and is bordered by the lip 166 and the arcuateedges 168 a and 168 b. Additionally, the front flap 162 comprisesgrooved perforations 172 a and 172 b that are adjacent cut-outs 174 aand 174 b. In the illustrative embodiment, the cut-outs 174 a and 174 bare configured to receive glue or other such adhesive, and are fixedlycoupled to the front wall 146. The grooved perforations 172 a and 172 bare located between cut-outs 174 a and 174 b and the trapezoidal edge ofthe front flap 162 that is adjacent the opening 170. The front flap 162also comprises front flap fold lines 176 a and 176 b that allow the lip166 to move about the axis defined by the front flap fold lines 176 aand 176 b, so the lip 166 can be easily inserted and released fromclosing slot 156.

Referring to FIG. 5B there is shown an illustrative embodiment of anisometric view of an assembled box 180 without any print placed on theblank 110. The second side wall 134 b is shown. The back face of the topwall 112 and the front flap/top wall fold line 164 has been folded overat a 90° angle so that the front flap 162 is coupled to front wall 146by inserting the lip 166 into closing slot 156.

The front flap 162 has an associated opening 170 that permits anillustrative patient to view a portion of the front wall 146. In theillustrative embodiment, the circular cuts 158 are visible through theopening 170. The front flap 162 has a rounded end that is adjacent theedge slot 154, wherein the edge slot 154 follows the fold line 152 andenables the lip 166 to easily separate from closing slot 156. In theillustrative embodiment, the cut-outs 174 a and 174 b are glued orfixedly coupled to the front wall 146. When a sealed assembled box 180is opened, the curved perforations 172 a and 172 b define where thefront flap 162 is perforated and separated from the cut-outs 174 a and174 b that become associated with the front wall 146.

Thus, the assembled box 180 is opened when the front flap 162 is liftedand separated from the front wall 146. When the front flap 162 isseparated from front wall 146, the front flap 162 may be slightly bentalong front flap fold lines 176 a and 176 b.

Referring to FIG. 6A there is shown a label area on a pre-assembledblank 190 that is similar to blank 110 described in FIG. 5A. Theinformation on label 192 is located on the front face of the blank 190and includes information that is associated with a particular patient.The label 192 may be affixed separately as a separate label, printed onthe blank 110 in the label area, or any combination thereof. The labelarea includes the top wall 112, and top side flaps 116 a and 116 bdescribed in FIG. 5A.

Referring to FIG. 6B there is shown a variety of printable areas on theback face of the assembled box 200. The first printable area 202 on thefront wall 146 includes printed letters 203 on the circular cuts 158corresponding to each day of the week where M is Monday, T is Tuesday, Wis Wednesday, Th is Thursday, F is Friday, Sa is Saturday, and Su isSunday. The second printable area 204 on the back face of the top wall112 and includes the week, the filling date, the patient name, and anillustrative bar code, and an interval or dosage period for theconsuming the medications, e.g. Morning. The third printable area 206 isdisposed on the back face of second side wall 134 b and includes anillustrative 800 number.

Referring to FIG. 7A there is shown an illustrative method for openingthe assembled box 200 with one hand. In the illustrative method, theuser places his thumb between the front flap 162 and the front wall 146and lifts the front flap up. The fold lines 176 a and 176 b allow thelip 166 to move about the axis defined by the fold lines 176 a and 176b, so the lip 166 can be easily released from closing slot 156 on thefront wall 146.

Referring to FIG. 7B, there is shown a folded box with an exposed labelarea or print area defined by the top wall 112 and top side flaps 116 aand 116 b as described above. The foldable box comprises a lid 210 a anda cavity configured to receive the strip or group of pouches. Theillustrative lid 210 a includes the top wall 112, top side flaps 116 aand 116 b, and the front flap 162.

An alternative lid 210 b is shown in FIG. 9A and consists of the topwall 112 and the front flap 162. As shown in FIG. 9A, the cavity isdefined by the bottom wall 126 adjacent to a back wall 118, two foldedside walls 212 and 214, and the front wall 146. Note, the folded sidewalls 212 and 214 are made by folding first side wall 134 a into firstside wall flap 140 a (see FIG. 5A) about side wall fold line 136 a andfolding second side wall 134 b into first side wall flap 140 b aboutside wall fold line 136 b, respectively.

Referring back to FIG. 7B and FIG. 5A, the illustrative lid 210 a isadjacent to a back wall 118 (shown in FIG. 5A) that is rotatable alongthe top wall/back wall fold line 124 (also shown in FIG. 5A). In theillustrative embodiment, the lid 210 comprises the label 192 with adescription of the medications housed by the foldable box. Additionally,the label 192 comprises a description of precautions corresponding tothe medications as described in further detail below in FIG. 10A.

Referring to FIG. 8A there is shown a side view of a strip of sevenseparable pouches as shown in FIG. 4A. The separable sealed pouches 220are folded over along the tearable ribbons so that each pouch isadjacent to the other pouch as shown in FIG. 8A and FIG. 8B, yetconnected to one another. Once the pouches are laid over one another,the folded combination 220 is placed in the cavity shown in FIG. 9A.

In the illustrative embodiment each pouch in the strip comprises a dateand a period. The date printed on the pouch indicates the date or daywhen the tablets are to be consumed and the interval or period printedon the pouch indicates the time of day when the tablets are to beconsumed.

Referring to FIG. 9A there is shown another illustrative folded box witha label area defined by the top wall. In the illustrative folded box222, the alternative lid 210 b is shown that consists of the top wall112 and the front flap 162. The cavity that receives the strip ofpouches is defined by the bottom wall 126 adjacent to a back wall 118,two folded side walls 212 and 214, and the front wall 146. The top wall112 is adjacent to the back wall 118 that is rotatable along the foldline 124. The bottom face of the top wall 112 has a label area or printarea that is visible when the lid 210 b of the folded box 222 is opened.The first area is disposed on the top wall and the first area isconfigured to receive a description for a plurality of differentmedications associated with a particular patient.

FIG. 9B shows the illustrative folded box of FIG. 9A in a closedposition. The front flap 162 adjacent to the top wall 112 is configuredto close the foldable box by rotating the top wall along the fold line124 and enables the front flap 162 to interface with the front wall 146.A closing slot 156 is disposed on the front wall 146 and is configuredto interface with the lip 166 disposed on the front flap 162, when thefoldable box is in a closed position. The front wall 146 furthercomprises an edge slot 154 that is at the interface between the frontwall 146 and the bottom wall 126, wherein the front flap 162 isconfigured to partially cover the edge slot 154. Thus, a means forclosing the box is described that includes having the front flap 162configured to close the foldable box by rotating the top wall 112 alongthe fold line 124 to enable the front flap 162 to interface with thefront wall 146.

Additionally, FIGS. 9A and 9B show that the illustrative box 222comprises a plurality of indicators corresponding to circular cuts 158that record when one of the seven pouches in the box has been consumed.The circular cuts 158 are visible through the opening 170 in the frontflap 162. In the illustrative example, the front wall 146 comprisesseven circular cut-outs 158 that correspond to a seven day week. Arecord is generated when a patient or caregiver “pushes out” thecircular cut. Generally, the patient or caregiver pushes out thecircular cut 158 when a pouch is removed from the folded box associatedor the tablets in the pouch are consumed. Alternatively, the circularcut outs may be embodied as tear-off tabs. Thus, the circular cuts 158provide a means for recording that the medications in the pouch havebeen taken. Other means for recording that the medications in the pouchhave been taken include using tear-off tabs, or other such recordingmeans.

Referring to FIGS. 10A-10G there is shown an illustrative label. Thelabel is an exploded view of the label 192. The label 192 may be affixedseparately or the label may be printed directly on the cardboard blank110 in the print area, or any combination thereof. The label area orprint area on the illustrative assembled box 200 includes the top wall112, and top side flaps 116 a and 116 b as described above. Theillustrative label 192 is not visible when the assembled box 200 isclosed. Note, the terms “label area” and “print area” are used hereininterchangeably.

The illustrative label 192 comprises a plurality of printed text thatmay include: the patient's name 240, the interval during which themedications are taken, e.g. morning, a picture of the patient 242,patient number 244, order number 246, a list of precautions 248, alisting of the medications 250, a listing of the time interval fortaking the medications 252, a prescription number 254, quantity oftablets 256 per prescription, quantity of refills 258, length ofprescription 260, the prescribing physician 262, the manufacturer of thetablets 264, and the lot number 266 corresponding to each tablet.Additionally, a picture 268 of each tablet is provided and the dosageconcentration 270 is provided for each medication. Information about theassociated generic drug 272 is also provided. Furthermore, an expirationdate may also be provided for each tablet or for each prescription.Further still, information regarding the generic or trademarked name ofthe medication may be provided, manufacturer information, corresponding“expiration dates,” personal contact information, physician contactinformation, insurance information, and other such informationassociated with the tablets in each container.

Further yet, a bar code 274 associates the medications in the foldablebox with a particular patient. The bar code 274 provides a means forassociating the medications in the foldable box with a particularpatient. The illustrative bar code 274 is not visible when the assembledbox 200 is in a closed position. Alternative means for associating themedications in the box to the patient include, by way of example but notof limitation, the patient's name, a serial number, a radio frequencyidentification (RFID) tag, or any other such method for associating anindividual with a particular item.

Referring to FIG. 11 there is shown an illustrative exterior label thatis applied to the exterior of the assembled box 200 and is visible whenthe assembled box 200 is in a closed position. The illustrative exteriorlabel 280 includes the patient name 282, the patient's physical address284, the dosing period 286 e.g. AM, a date 288, and a bar code 290. Thebar code 290 associates the medications in the assembled box 200 withthe particular patient. Alternatives to using a bar code as a means forassociating the medications in the foldable box with the particularpatient include using a serial number, an RFID tag, or any other suchmethod for associating an individual with a particular item. The date288 may be associated with date the prescription was filled, the datethat the medication corresponding to the first pouch in the strip, theexpiration date for the medications, or another such significant date.By way of example and not of limitation, the dosing period may be one offour dosing periods, namely, morning, noon, dinner, or bedtime. Althoughnot shown, other information may also be on the exterior label mayinclude the week number corresponding to a strip, patient numberinformation, order number information, and other such information.

A means for indicating when the medications in each pouch are to betaken is presented herein. By way of example and not of limitation, themeans for indicating when the medications are to be taken includelabeling the pouch with dosage period information and including thedosage period information on the interior of foldable box, on theexterior of the assembled box, in a separate booklet associated with thepouches, or a combination thereof.

Referring to FIG. 12 there is shown a 30-day tablet regimen for thepatient medication management system that uses the seven-day box. Apatient medication management system 300 provides a compliance packagingsolution. The patient medication management system 300 described hereinprovides a compliance package because, firstly, an action is required bythe patient or caregiver that requires identifying the appropriatedosage period, e.g. morning, and selecting the appropriate pouch.Secondly, the patient opens the appropriate pouch and consumes themedication. Thirdly, the patient or caregiver records the consumption ofthe medication by removing or pressing the circular cuts.

The patient medication management system 300 comprises a plurality ofsealed pouches that are grouped into four separate strips 302, 304, 306and 308. The first strip 302 is a seven day strip that covers anillustrative seven day period, Week 1, and is associated with one dosingperiod. In the illustrative embodiment, the dosage period is selectedfrom the group of dosage period intervals consisting of a morning dosageinterval, a noon dosage interval, an evening dosage interval, or abedtime dosage interval.

The first strip 302 is placed into the illustrative folded box 310 thathas the tablets corresponding to the first week of the 30-day regimen.The second strip 304 is a seven day strip that covers an illustrativeseven day period, Week 2, and is associated with the same dosing periodas Week 1. The second strip 304 is associated with folded box 312 thathouses the tablets corresponding to the second week of the 30-dayregimen. The third strip 306 is a seven day strip that covers anillustrative seven day period, Week 3, and is associated with the samedosing period as Weeks 1 and 2. The third strip 306 is associated withfolded box 314 that corresponds to the third week of the 30-day regimen.

The fourth strip 308 includes a seven day grouping of pouches 316 thatcovers an illustrative seven day period, Week 4, and is associated withthe same dosing period as Weeks 1, 2, and 3. Additionally, an emptypouch 318 is included with the fourth strip 308 that provides a reminderto place another order and an illustrative 800 number to assist inplacing the refill order. Furthermore, a two day grouping of pouches 320covers two additional days. The fourth strip 308 is associated withfolded box 322 that houses the tablets corresponding to the fourth weekof the 30-day regimen. Thus, the fourth strip 308 includes nine pouchesthat complete the 30-day regimen.

Each of the strips 302, 304, 306 and 308 are placed in the correspondingfolded box 310, 312, 314 and 322, respectively. Each folded box or“primary container” is configured to receive at least seven pouches.Note, the terms folded box, assembled box, and “primary container” areused interchangeably though out this patent. Thus, each primarycontainer is configured to receive at least seven pouches thatcorrespond to the particular dosage period and the illustrative primarycontainer is labeled with the dosage period corresponding to themedications. Additionally, each primary container may be labeled withthe patient name and dosage period as described above.

Each folded box or primary container comprises a plurality of dailyindicators corresponding to a seven-day period that are disposed on theprimary container. The daily indicators provide a means for recordingthat the medications in the pouch have been taken. An illustrativeembodiment of the daily indicators has been provided above thatdescribes a plurality of circular cuts 158 on the folded box. Each ofthe daily indicators is configured to indicate that the medications inthe pouch have been taken, thereby providing a means for compliancepackaging.

In the illustrative 30-day regimen, the sealed pouches associated withstrips 302, 304, 306 and 308 include sealed pouches with a plurality ofdifferent tablets that correspond to different medications and/orvitamins. The different medications are associated with at least oneprescription and each tablet includes an appropriate dosage consistentwith the prescription. Each of the sealed pouches is labeled to show themedications in the pouch and labeled with a particular dosage periodthat includes at least one daily interval for consuming the medicationsin the pouch.

Referring to FIG. 13 there is shown a secondary container that receivesfour primary containers or assembled boxes. The secondary container 330is configured to house the four illustrative primary containers 310,312, 314 and 322 described above. The illustrative secondary container330 is composed of a cardboard material. The secondary containerincludes a lid 332 that is rotatable about a back fold line. Theillustrative lid 332 includes a plurality of side flaps.

In the illustrative embodiment, the secondary container 330 is sealedwith a label 334 that affixes the lid 332 to the body of the secondarycontainer 330. The illustrative label 334 includes the patient's name336 and a general description that there are multiple prescriptionpouches 338 in the secondary container. The illustrative label 334 mayalso include additional information such as the dosing interval ordosing period, the prescribing physician, one or more bar codes, apatient serial number, or additional information about the differentmedications, such as the type of prescriptions within the box, thepharmacy that filled the prescription, or any other such information. Toopen the illustrative secondary container 330, the label 334 is simplybroken by the patient or caregiver and access is provided to the 30-dayregimen in primary containers 310, 312, 314, and 322.

Additionally, a medication summary sheet 340 may also be included orhoused by the secondary container 330. The medication summary sheet 340provides detailed information about the tablets in each pouch. Themedication summary sheet 340 may include warnings, precautions, sideeffects, dosage, administration, clinical pharmacology, and picturescorresponding to each medication. For example, the medication summarysheet may include summaries of the various medications being taken andsummaries of the side effects. In general, the medication summary sheetprovides the patient with a detailed summary of the medications beingtaken. The medication summary sheet 340 may also include the name of thepatient, a bar code, or other such identification means that ensuresthat the correct medication summary sheet 340 is associated with thecorresponding prescription.

The illustrative secondary container 330 housing the four smallercontainers may be distributed or dispensed at a retail pharmacy, by mailorder, or a combination thereof. For the mail order embodiment, amailing label is also associated with the secondary container. Themailing label enables delivery of the patient medication to a mailingaddress corresponding to the patient.

Referring now to FIG. 14 there is shown a plurality of differentsecondary containers corresponding to four different dosage periods. Inthe illustrative embodiment, the first dosage period is the morningdosing period corresponding to the “AM” secondary container 330. Thesecond dosage period is the lunch-time dosing period corresponding tothe “Noon” secondary container 342. The third dosage period is thedinner or evening dosage period associated with the “PM” secondarycontainer 344. The fourth illustrative dosage period is the late nightdosage period corresponding to the “Bedtime” secondary container 346.Additional dosage periods or intervals may also be necessary and theabove dosage periods are illustrative and not limiting.

The secondary containers may also be combined in a tertiary container(not shown). The illustrative tertiary container may be used forshipping purposes or simply to store and transport the secondarycontainers.

Referring to FIG. 15 there is shown an illustrative flowchart for usingthe patient medication management system described above. The method 350is initiated at block 352 where a secondary container associated withthe appropriate time interval or dosage period is selected. As describedabove, the illustrative dosage periods are morning, lunch, dinner andbedtime.

The patient then proceeds to block 354 where the patient opens thesecondary container and selects the appropriate primary container atblock 356. At block 358, the primary container is opened. Subsequently,the appropriate multiple prescription pouch is selected at block 360 andthe patient may take or consume the tablets in the multiple prescriptionpouch.

At block 362, the patient or caregiver then records that the pouch hasbeen removed by pushing out the appropriate circular cut on the primarycontainer. This recording step completes the compliance packagingprocess. Alternatively, the patient may take the tablets at block 364after pushing out the circular cut-out.

At decision diamond 366, the patient or caregiver determines whether toplace a new order. The decision may be triggered by the empty pouch 318shown in FIG. 12 that reminds the user that a new order or refill ordershould be placed, or the decision may be triggered by the patient orcaregiver taking their own initiative. The order is then placed at block368, where an illustrative refill order is placed.

If there is no need to place another order, the primary container isclosed and returned to the secondary container that is also closed. Themethod then proceeds to decision diamond 370 where the patient waits forthe next time interval or dosage period. When the next dosage periodarrives, the method returns to block 352 and the entire cycle isrepeated. Those skilled in the art shall appreciate that various designparameters, requirements, rulings, orders, and statutes may affect theprecise method employed.

Compliant packaging may also include a compliant package having aplurality of different tablets corresponding to one or moreprescriptions from one or more medical doctors. The compliant packagecontents are consumed at a predetermined interval consistent with theprescription. Some compliant packaging solutions may not record thateach of the tablets is consumed. For example, and illustrative 30-dayfoldable box configured to receive the plurality of pouches is presentedherein.

Referring to FIGS. 16A-16C, there is shown an isometric view of the30-day tablet dispensing container 400. In general, the illustrative30-day tablet dispensing container is a foldable box that includes a topwall, a front side wall, a right-side wall, a back side wall, aleft-side wall and a bottom wall. The top wall has one end fixedlycouple to the foldable box and an opposite end that provides a foldablelid. The front side wall has a removable lid that is bordered by aplurality of perforations. The right-side wall abuts the front side walland the top wall. The back side wall abuts the right-side wall and thetop wall. The left-side wall abuts the top wall and is between the backside wall and the front side wall. The bottom wall abuts the frontside-wall, the right-side wall, the back side, and the left-side wall.The container is formed to receive a plurality of pouches as describedherein.

By way of example and not of limitation, the illustrative cardboard usedto construct container 400 includes an outer smooth layer of paper and athick interior layer. The outer smooth layer may receive printed text orimages using an illustrative laser printer, ink jet printer, or othersuch printing means. Additionally, the outer layer may also beconfigured to receive a label that is affixed thereto.

In the illustrative embodiment, a perforated, removable lid 404 makes upa large portion of the front side wall 406 and top wall 402 of theillustrative container 400. The lid can be partially or completelyremoved in order to access the medicament pouches within the container400. In one embodiment the lid 404 may only occupy one wall such as thefront side wall. In the illustrative embodiment, the lid occupies thefront side wall 406 and extends to the top wall 402.

The illustrative top wall 402 has one end fixedly coupled to thefoldable box and an opposite end that provides a foldable lid. Asecondary label 475 is configured to seal the foldable lid on the topwall. In the illustrative embodiment, the secondary label has a bar code(shown in FIG. 19) and includes the time interval when the tabletsshould be administered or taken. In the illustrative embodiment, thesecondary label 475 visible on top wall 402 of the container 400indicates the time period 470, the filling date 474, and theprescription start date 476 listed above the perforations of lid 404.

A portion of the primary label 500 is visible in FIG. 16, shown affixedto the container 400 such that it covers the lower portion of the leftside wall of the container 400. The label goes on to cover the lowerportion of the back side wall and right-side wall of the container 400.In the view shown in FIG. 16, the top wall 402, front wall 406, and leftside wall 410 of container 400 are visible. The label includes importantinformation related to the prescriptions and to the individual patientfor whom the medications were prescribed.

The illustrative primary label 500 may include, for example, patient andmedication data such as patient name and number, names of prescribingphysicians, medicine(s), dosage strength(s), medicine quantity(s), colorimages of the medicine(s), prescription number(s), NDA number(s),warning(s), dosage period(s), administration schedule(s), and the like.The illustrative label strip is configured such that all informationnecessary for drug identification and administration is affixed to thecontainer 400.

The illustrative container 400 comprises a cavity defined by the frontside wall, the right-side wall, the back side wall, the left-side walland the bottom wall, wherein the cavity is configured to receive theplurality of filled pouches that are associated with a bar code. Theplurality of filled pouches includes at least 28 filled pouches, inwhich each pouch comprises a plurality of different tablets associatedwith a prescription. The barcode is associated with at least one of thepouches, wherein the barcode is associated with the prescription.

Referring to FIGS. 17A-17E there is shown an illustrative primary label500. The primary label 500 is the large label that is affixed to theside walls. The secondary label 475 is affixed between the top wall andthe back side wall. The primary label 500 is affixed to the foldable boxand includes a description of the medications and the barcode associatedwith the prescriptions.

The illustrative bar code provides a means for associating the labelsand pouches with a particular patient. By way of example and not oflimitation, the means for associating the pouches may also include aradio-frequency identification (RFID) component, writing, or other suchassociative element capable of associating the labels, pouches, andparticular package with a particular patient

Starting from the left side of FIG. 17A, the label includes patient anddosage period information including time period 502, patient name 504,barcode 506, patient number 508, and order number 510. Some embodiments,particularly those embodiments suitable for use in a long-term carefacility, may also include a photograph (not shown) of the patient inthis portion of the label with other identifying information. In otherillustrative embodiments, the label may include information about avariety of different prescriptions and medications associated with eachof these different prescriptions. Furthermore, the primary label mayinclude an expiration date for each prescription.

The time period 502 refers to the particular time of day that thepatient must take the tablets within the container. In this illustrativelabel, the time period is “Morning.” The numeral “1” next to the word“Morning” is another reference to the time period. In this case“Morning” is the first time period during which the illustrative patientmust take medications.

A barcode 506 is printed on the illustrative label 500. A barcode mayappear on each element of the container and its packaging including theillustrative label 500, the container 400 as shown in FIG. 19, and anillustrative strip of packets or pouches configured to be placed withincontainer 400. The barcodes may encode important information such astime period 502, Patient Name 504, Patient Number 508, and/or OrderNumber 510. The barcodes are associated with one another duringcontainer assembly and filling, improving order verification by ensuringthat the appropriate pouches, having been filled with medicamentsassociated with a particular patient 504 and time period 502, are placedin the appropriate container 400 that is associated with the particularpatient 504 and time period 502. Barcodes are also used to ensure thatthe appropriate label 500 is affixed to the appropriate container 400associated with a particular patient 504 and time period 502. Thebarcode may also be associated with a variety of different prescriptionsand the corresponding expiration date for each prescription.

Referring now to the “Precautions” section of the illustrative label500, there is shown a list of drug precautions 514 associated with themedicaments in the illustrative order. Each drug precaution for eachdrug found within the container is present in the Precautions section.The Precautions section may also include information on synergistic,agonist, or antagonist effects that may occur among one or moremedications in the order. Each precaution 514 is associated with anumeral 512A, or with another easy-to interpret symbol. Each precautionapplies to at least one drug in the order, but may apply to more thanone drug.

The next column of label 500 contains another set of numerals 512B thatmap to the numerals 512A and thus to drug precautions 514. For example,one of the drug precautions 514 instructs patients to refer to thePatient Info Booklet for additional cautions. The 512A number “6” isassociated with the Patient Info Booklet precaution. In turn, the 512Bnumber “6” is associated with several of the prescription tablets 518.Other easily interpreted symbols could be used in place of numbers, butit is essential that the first set 512A maps exactly to the second set512B.

Referring now to FIG. 17D, the next part of the label 500 shows druginformation, including color images 516 of each drug in the order andthe name 518 of each drug in the order. The numbers 512B are groupedsuch that each ‘cell’ containing a group of numbers 512B is associatedwith exactly one drug 518. The numbers 512B show which listedprecautions are associated with each prescription in the order. Asshown, each precaution 514 maps to exactly one number 512A, but eachprecaution 514 and its corresponding number 512B may apply to more thanone drug in an order. That is, each number found in the set of numbers512A may appear associated with any or all drugs 518 in the order,depending on which group of numbers 512B appears next to the drug image516 and name 518.

For example, on the illustrative label 500, six precautions 514 areshown, each of which is in turn associated with exactly one number 512A.The first drug 518 listed on the label is “ARICEPT.” Next to the word“ARICEPT” is shown the color image of the drug 516, and on the otherside the 512B numbers “1, 2, 3, & 4” are listed. This means that eachprecaution 514 associated with each of the 512A numbers “1”, “2”, “3”,and “4” applies to “ARICEPT.” Further, the number “4” appears in thegroups of numbers 512B adjacent to three of the six illustrative drugs,and number “6” appears in the groups of numbers 512B adjacent to five ofthe six drugs listed, while the 512B number “5” is listed next to onlyone drug. This means that the precaution 514 associated with 512A number“5” applies only to one drug, while the precaution 514 associated with512A number “6” applies to almost every drug in the order.

The “Medication/Rx#” section of FIG. 17B includes the drug images 516and the drug name 518 mentioned above, in addition to the unit dosage520, the drug format 521, and the prescription number 528. Thus, avariety of different prescriptions may be consolidated and integratedinto the primary label 500. The prescriptions may also include differentexpiration dates as indicated by the dates in column 522, shown in FIG.17C. The color images 516 show both the front and the back of eachtablet. The color images allow the patient or a caregiver to identifyindividual medications within each pouch by using the label 500 as akey. If a patient's medication must be changed in the middle of a 30-dayprescription order, this allows the patient to keep taking medicationsfrom the current 30-day period by merely discarding tablet associatedwith the discontinued prescription after opening the packet or pouch,and consuming the remaining medications.

The next column of text, shown in FIG. 17C, displays refill information522 including the number of refills left on the prescription for thatdrug, the quantity of tablets that is supplied each time theprescription is filled, and the date that the prescription expired. Thenext column of text includes the prescribing practitioner's name 524 foreach drug 518, and the last column includes manufacturer information 526including the name of the manufacturer or other manufacturer data.

Referring to FIG. 18, there is shown a side view of the front side wallfor the unopened 30-day tablet dispensing container. The front part oflid 404 is visible on the front side wall. Lid 404 is removed by thepatient or a caregiver in order to access the contents of the container400. By way of example, the front lid 404 and the space below the lidhave areas that display the name of the pharmacy that provides thecontainer 400.

Referring to FIG. 19 there is shown a side view of the back side wall ofthe 30-day tablet dispensing container. Part of the primary label 500 isshown affixed to the lower portion of the back side wall 426 of thecontainer 400. Additionally, part of the secondary label 475 is alsoshown. The visible portion of the primary label 500 includes themedicament images 516, the drug name 518, the dosage amount 520, thedosage format 521, and the drug number 528 is shown. The upper portionof the back side wall 426 of container 400 includes a portion of thesecondary label 475 that also has additional printed information thatincludes dosage period 550, patient name 552, patient number 554, ordernumber 556, and barcode 558.

Referring to FIGS. 20A-20B, there is shown a side view of theillustrative right-side wall of the 30-day tablet dispensing container.The visible portion of primary label 500 is affixed to the lower portionof right side wall 420. The visible label portion includes the timeperiod 502, patient name 504, barcode 506, patient number 508, ordernumber 510, numbers 512A associated with precautions 514 (not shown),and numbers 512B. In this illustrative embodiment, the upper portion ofthe right side 420 includes pharmacy name 564 and contacttelephone/facsimile number 560. In this illustrative embodiment, theright side 420 also includes certain additional legal information orwarnings 566 regarding the package and its contents.

During the process of assembling and filling the 30-day tabletdispensing container, bar code 558 may be printed or affixed to the backof an assembled, unfilled container before any other patient-specificinformation is applied. Then, as the process continues, barcode 506 fromthe illustrative label 500 may be compared to barcode 558 that isalready present on the unfilled container before the label 500 isaffixed to the container. Lastly, the barcode 564 that is found on theback of each tablet pouch may be compared with the barcode 506 disposedon the label 500 and/or the barcode 558 disposed on the back side of thecontainer. If the barcodes are properly associated, i.e. they “match”,then the strip of packets will be placed into the associated containerbefore sealing the container. The barcode scanning can be accomplishedwith hand-held devices or may be automated.

Referring to FIG. 21 there is shown a side view of the illustrativeleft-side wall of the 30-day tablet dispensing container. The visibleportion of primary label 500 is affixed to the lower portion of leftside wall 410. The label portion includes the refill information 522including quantity 534, number of refills 536, the date 538 that theprescription is good through, prescribing practitioner names 524, andmanufacturer information 526. In this illustrative embodiment, the upperportion of the left side 410 includes illustrative pharmacy name 568 andcontact address 562.

In FIG. 22 there is shown a top view of the top wall of the unopened30-day tablet dispensing container. The top wall 402 includes the dosageperiod 470, the dosage period number 472, the date 474 that theprescription was filled, and the date 476 that marks the first day ofthe about 30-day period during which the enclosed medicaments should betaken. A bottom view of the 30-day tablet dispensing container is shownin FIG. 23 that includes folded elements and glued elements of thecontainer that make up the bottom wall 480 when the foldable box isassembled.

Referring to FIG. 24 there is shown an illustrative front view of theopened 30-day tablet dispensing container that reveals illustrativepouches where the front lid 404 (not shown) has been removed to revealmedicament packets within. Typically, the lid is removed after the userverifies that the medications are prescribed to the person that is aboutto take the medication by checking the patient name. The user would thenverify that the time period on the illustrative container 400corresponds to the current time of day. If this is the first time thecontainer has been used, the illustrative user would then remove the lid404 from the top 402 and/or the front 406 of the illustrative container400 to reveal the contents. Next, the user would reach into thecontainer and remove the first packet or pouch that containsmedicaments. The user would then verify that the pouch or packet has thecurrent date before opening the pouch. While the user may also re-verifythat the pouch or packet also has the correct patient name and dosageperiod, this step is unnecessary due to the barcode verification(described above) used during the filling process.

Once the user has verified that the pouch removed from the container isfor the correct person, date, and time period, the user may then openthe pouch. The user will then administer the medication to the patient(himself or someone else). The patient will take the medication anddiscard the empty pouch. The process will be repeated for the nextdosage period, such as mid-day.

The illustrative pouch described above can be opened with only one hand,making it easier for even for those with limited motion toself-administer even complex medication regimens. In this way, the30-day tablet dispensing container system described herein provides acompliance mechanism that is simple to understand and intuitive to usefor patients and caregivers alike.

The illustrative 30-day tablet dispensing container offers additionalbenefits for those with a variety of conditions that affect speechand/or upper limb mobility, including but not limited to disorders likearthritis, effects of a stroke, or early stage dementia. Many of thesepatients develop their conditions later in life, and these patients maydislike relying on a caregiver to provide information to physicians orto self-administer complex medication regimens. The 30-day tabletdispensing container system helps these patients address both issues.For a patient, the illustrative 30-day tablet dispensing containerprovides drug regimen information and facilitates communication with aphysician, a nurse, a third party, a spouse, a caregiver, or other suchindividual. The 30-day tablet dispensing container also allows theillustrative patient to maintain independence by taking charge of theirown medications.

It is to be understood that the detailed description of illustrativeembodiments are provided for illustrative purposes. The scope of theclaims is not limited to these specific embodiments or examples. Thefoldable box holding a plurality of pouches, manufacturing separablepouches with a center cut blade, and patient medication managementsystem provides patients or caregivers with the peace of mind of knowingthat the right medication will be taken at the right dosage period eachday. Thus, the patient medication management system and method removesthe worries surrounding medication mishaps and enabling the patient tolive independently longer. Various structural limitations, elements,details, and uses can differ from those just described, or be expandedon or implemented using technologies not yet commercially viable, andyet still be within the inventive concepts of the present disclosure.The scope of the invention is determined by the following claims andtheir legal equivalents.

1. A system for manufacturing a plurality of separable pouches, thesystem comprising: a means for forming a plurality of sealed pouches, inwhich each pouch includes a plurality of different tablets correspondingto different medications; a center cut blade that comprises, a side cuton each end of the blade, a center cut in the middle of the blade, andat least one perforation cut between each side cut and the center cut; ameans for separating each sealed pouch with the center cut blade,wherein the sealed pouch includes a sealed top end, a sealed bottom end,and two sides, in which at least one side is also sealed; and eachsealed pouch joined to an adjacent pouch by at least two tearableribbons, wherein each sealed pouch comprises, a side cut on each side ofthe top end and bottom end of the sealed pouch, a center cut on the topend and bottom end of the sealed pouch, and at least one perforationbetween each side cut and the center cut.
 2. The system of claim 1further comprising at least three perforations between each side cut andthe center cut.
 3. The system of claim 2 further comprising at leastfour ribbons between each side cut and the center cut, wherein the firstribbon is disposed between the side cut and the first perforation, thesecond ribbon and third ribbon are each disposed between perforations,and the fourth ribbon is disposed between the third perforation and thecenter cut.
 4. The system of claim 1 wherein the center cut length isgreater than the length of each side cut.
 5. The system of claim 1wherein the center cut length is greater than the length of each sidecut, the system further comprising at least three perforations betweeneach side cut and the center cut, and at least four ribbons that areeach disposed between two cuts that consist of the side cuts, the centercut or the perforation cuts.
 6. The system of claim 1 further comprisinga group of seven pouches that correspond to a seven day supply ofmedications.
 7. The system of claim 1 further comprising a group ofthirty filled pouches and one empty pouch, wherein, twenty-eight filledpouches corresponding to a four-week supply of medications that areadjacent to an empty pouch that provides a reminder to re-ordermedications that is adjacent to two filled pouches corresponding to atwo-day supply of medications.
 8. The system of claim 1 furthercomprising thirty pouches that correspond to a thirty day supply ofmedications.
 9. The system of claim 1 further comprising thirty pouchesthat correspond to a thirty day supply of medications, wherein thethirty pouches are received by a foldable box that includes, a top wallhaving one end fixedly couple to the foldable box and an opposite endthat provides a foldable lid; a front side wall having a removable lidthat is bordered by a plurality of perforations; a right-side wall thatabuts the front side wall and the top wall; a back side wall that abutsthe right-side wall and the top wall; a left-side wall that is betweenthe back side wall and the front side wall, the left-side wallconfigured to abut the top wall; a bottom wall that abuts the frontside-wall, the right-side wall, the back side, and the left-side wall; acavity defined by the front side wall, the right-side wall, the backside wall, the left-side wall and the bottom wall; a barcode associatedwith one of the pouches, wherein the barcode is associated with theprescription; a label affixed to the foldable box, wherein the labelincludes a description of the medications and the barcode associatedwith the prescription; wherein the cavity is configured to receive theplurality of filled pouches that are associated with the bar code; andwherein one of the walls is configured to receive the label associatedwith the bar code.
 10. A system for manufacturing a plurality ofseparable pouches, the system comprising: a heated roller configured toseal each pouch, in which each pouch includes the plurality of differenttablets corresponding to different medications, each sealed pouchincludes a sealed top end, a sealed bottom end, and two sides, in whichat least one side is also sealed; a center cut blade configured to beaffixed to the heated roller that separates each sealed pouch, thecenter cut blade comprises, a side cut on each end of the blade, acenter cut in the middle of the blade, and a plurality of perforationcuts between each side cut and the center cut; and each sealed pouchjoined to an adjacent pouch by a plurality of tearable ribbons, whereineach sealed pouch comprises, a side cut on each side of the top end andbottom end of the sealed pouch, a center cut on the top end and bottomend of the sealed pouch, and a plurality of perforations between eachside cut and the center cut.
 11. The system of claim 10 furthercomprising at least three perforations between each side cut and thecenter cut.
 12. The system of claim 11 further comprising at least fourribbons between each side cut and the center cut, wherein the firstribbon is disposed between the side cut and the first perforation, thesecond ribbon and third ribbon are each disposed between perforations,and the fourth ribbon is disposed between the third perforation and thecenter cut.
 13. The system of claim 10 wherein the center cut length isgreater than the length of each side cut.
 14. The system of claim 10wherein the center cut length is greater than the length of each sidecut, the system further comprising at least three perforations betweeneach side cut and the center cut, and at least four ribbons that areeach disposed between two cuts that consist of the side cuts, the centercut or the perforation cuts.
 15. The system of claim 10 furthercomprising a group of seven pouches that correspond to a seven daysupply of medications.
 16. The system of claim 10 further comprising agroup of nine filled pouches and one empty pouch, wherein seven filledpouches corresponding to a seven day supply of medications are adjacentto an empty pouch that provides a reminder to re-order medications thatis adjacent to two filled pouches corresponding to a two day supply ofmedications.
 17. The system of claim 10 further comprising thirtypouches that correspond to a thirty day supply of medications.
 18. Thesystem of claim 10 further comprising thirty pouches that correspond toa thirty day supply of medications, wherein the thirty pouches arereceived by a foldable box that includes, a top wall having one endfixedly couple to the foldable box and an opposite end that provides afoldable lid; a front side wall having a removable lid that is borderedby a plurality of perforations; a right-side wall that abuts the frontside wall and the top wall; a back side wall that abuts the right-sidewall and the top wall; a left-side wall that is between the back sidewall and the front side wall, the left-side wall configured to abut thetop wall; a bottom wall that abuts the front side-wall, the right-sidewall, the back side, and the left-side wall; a cavity defined by thefront side wall, the right-side wall, the back side wall, the left-sidewall and the bottom wall; a barcode associated with one of the pouches,wherein the barcode is associated with the prescription; a label affixedto the foldable box, wherein the label includes a description of themedications and the barcode associated with the prescription; whereinthe cavity is configured to receive the plurality of filled pouches thatare associated with the bar code; and wherein one of the walls isconfigured to receive the label associated with the bar code.
 19. Asystem for manufacturing a plurality of separable pouches, the systemcomprising: a heated roller configured to seal each pouch, in which eachpouch includes the plurality of different tablets corresponding todifferent medications, and each sealed pouch includes a sealed top end,a sealed bottom end, and two sides, in which at least one side is alsosealed; a center cut blade configured to be affixed to the heated rollerthat separates each sealed pouch, the center cut blade comprises, a sidecut on each end of the blade, a center cut in the middle of the blade,and at least one perforation cut between each side cut and the centercut; and each sealed pouch joined to an adjacent pouch by a plurality oftearable ribbons, wherein each sealed pouch comprises, a side cut oneach side of the top end and bottom end of the sealed pouch, a centercut on the top end and bottom end of the sealed pouch, wherein thecenter cut length is greater than the length of either side cut, atleast one perforation between each side cut and the center cut, and atleast two ribbons between each side cut and the center cut, wherein thefirst ribbon is disposed between the side cut and the first perforationand the second ribbon is disposed between the first perforation and thecenter cut.
 20. The system of claim 19 further comprising a group ofseven pouches that correspond to a seven day supply of medications. 21.The system of claim 19 further comprising a group of nine filled pouchesand one empty pouch, wherein seven filled pouches corresponding to aseven day supply of medications that are adjacent to an empty pouch thatprovides a reminder to re-order medications that is adjacent to twofilled pouches corresponding to a two day supply of medications.
 22. Thesystem of claim 19 further comprising thirty pouches that correspond toa thirty day supply of medications.
 23. The system of claim 19 furthercomprising thirty pouches that correspond to a thirty day supply ofmedications, wherein the thirty pouches are received by a foldable boxthat includes, a top wall having one end fixedly couple to the foldablebox and an opposite end that provides a foldable lid; a front side wallhaving a removable lid that is bordered by a plurality of perforations;a right-side wall that abuts the front side wall and the top wall; aback side wall that abuts the right-side wall and the top wall; aleft-side wall that is between the back side wall and the front sidewall, the left-side wall configured to abut the top wall; a bottom wallthat abuts the front side-wall, the right-side wall, the back side, andthe left-side wall; a cavity defined by the front side wall, theright-side wall, the back side wall, the left-side wall and the bottomwall; a barcode associated with one of the pouches, wherein the barcodeis associated with the prescription; a label affixed to the foldablebox, wherein the label includes a description of the medications and thebarcode associated with the prescription; wherein the cavity isconfigured to receive the plurality of filled pouches that areassociated with the bar code; and wherein one of the walls is configuredto receive the label associated with the bar code.